Japan’s 2012 New Drug Approval Period Shortest Since 2000
This article was originally published in PharmAsia News
The approval time for new drugs in Japan was a median of 9.5 months in 2012, 0.6 months shorter than the previous year and shorter than any year since 2000, according to research carried by the JPMA Office of Pharmaceutical Research.
You may also be interested in...
Many materials subject to order, APIs needed for OTC as well as Rx drugs, are supplied by companies outside the US, and China accounts for the bulk of them. The order didn't specify countries and products, leaving decisions to FDA.
Order sets a path for federal government to use its power as a purchaser of pharmaceuticals to nurture a high-tech domestic pharma manufacturing sector that would increase resilience against threats that could isolate the US from countries like China that are important nodes in the global manufacturing supply chain.
Will the US FDA agree to more structured communications amid its struggles with the existing meeting workload?